To facilitate and lead projects related to Arthrex sponsored clinical research activities.
Essential Duties and Responsibilities:
Provide accurate status reports and updates of assigned clinical research projects
Facilitate data report creation to meet Arthrex and researcher goals
Facilitate appropriate documentation to maintain compliance with the AP and Compliance department
Facilitate clinical contract agreements between Arthrex and the Site for Arthrex initiated studies
Assist the data management team with electronic data capture systems CRF design, eTMF design, CTMS design and user testing for assigned studies
Audit potential research investigators to maximize Arthrex clinical research efforts
Respond to site inquiries for study related needs
Site training for data collection clinical research initiatives
Facilitate preparation of pending clinical research projects for review in global research review
Monitor data collection compliance and communicate with sites to optimize data collection compliance
Provide the main line of communication with research sitesFacilitate IRB approval at the site level
Create protocols, case report forms and information packets for clinical studies
Recruit and qualify investigators to conduct clinical research
Initiate site start-up activities for clinical research for Arthrex sponsored studies
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Familiarity with orthopedic terminology is preferred
4 years’ relevant clinical research experience required
Bachelor’s degree required
One year of industry sponsor or CRO employment required
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Good communication, documentation, and record keeping skills are required.
A basic ability to identify a research hypothesis and proposed outcomes measures to address the hypothesis is required
The ability to read surgical techniques and have a basic understanding of the medical devices necessary to perform the procedure is preferred
Ability to organize and manipulate large data sets.
Experience managing research contracts and protocol development is preferred.
PLEASE USE LINK BELOW TO APPLY ONLINE. ONLY CANDIDATES THAT SUBMIT ONLINE APPLICATIONS WILL BE CONSIDERED FOR EMPLOYMENT.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
About Arthrex, Inc.
We are a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 7,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.
Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately-held company with a family business culture that is committed to delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.
Arthrex’s corporate headquarters is located in Southwest Florida. Additional locations include a global division in Munich, Germany as well as several subsidiaries and distribution centers throughout the Eastern and Western Hemispheres.
Eastern Hemisphere: Germany, France, Belgium, Austria, England, Switzerland, Sweden, Netherlands, Denmark, Poland, Spain, China, Korea and Japan.
Western Hemisphere: Arthrex Manufacturing, Inc.; Arthrex California, Inc.; Arthrex Califo...rnia Technology; Arthrex Iberoamerica; and Arthrex Canada.
We invite you to learn more about Arthrex and the positive contributions we are making to medicine and the communities we serve by visiting our website.